2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen

Lilly

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Transitional Cell; Urologic Neoplasms

Treatments: Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191971

B9E-JE-BL21

7994

Details and patient eligibility

About

To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for patients with transitional cell carcinoma of urothelium

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically and/or cytologically confirmed TCC
• Received 1st line chemotherapy for locally advanced or metastatic TCC with CDDP regimen
• To have at least one measurable region
• PS: 0-2
• To have adequate organ function (bone marrow, liver and renal function)

Exclusion criteria

• To have Interstitial pneumonia or pulmonary fibrosis
• Within 4 weeks after the latest chemotherapy or radiotherapy
• To have brain metastasis with symptom
• To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)